Consumables

Custom Fluidic Consumable Design Development and Manufacturing

The Gener8 consumable engineering team has decades of experience with custom fluidic consumable design, development, and manufacturing of medical devices.

 

Complex Fluidic Cartridges
Complex fluidic cartridges are in our DNA. 

We can bridge the gap between science and engineering by internalizing product requirements quickly and efficiently, leading to the rapid development of a system that meets your needs. Our structured approach to solving your design challenges leaves no avenue unexplored and opens worlds of possibilities for your product.

Our Development Services Include:

  • - Product Requirement Generation
  • - Rapid Concept Development
  • - Subsystem De-risking Through 3D Printing or Prototype Injection Molded Assemblies
  • - Design for Manufacturing
  • - Production Level Metrology
  • - Design Control Per ISO 13485
  • - Industrial Design
  • - Analysis via FEA (finite element analysis) or CFD (computational fluid dynamics)
  • - Material Selection
  • - Design Verification Testing

Decades of Experience at Your Service

Assay Automation

Consumable designs can often translate complex, multi-step bench assays into one or two user steps, which enables your device to meet stringent user requirements or be granted a CLIA waiver. Expertise in high-volume manufacturing and DFM (design for manufacturing) is a core capability, enabling the development of low-cost, high-quality, market-ready designs.

Common system requirements include:

 

  • Sample collection
  • Plasma separation
  • RNA/DNA purification
  • Cell lysis
  • Fluid metering/de-bubbling
  • Fluid storage, mixing and delivery
  • Magnetic bead handling
  • Optical detection
  • PCR reactions
  • Lyophilized reagent handling
  • Cell culture
  • Blister pack design and integration
  • High pressure (>20psi) and vacuum capabilities